EYLEA 40 mg/ml Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the Adult Patient

Eylea 40 mg/ml solution for injection in a prefilled syringe

aflibercept

ADULTS

If you want information for caregivers of premature babies, see the end of section 6.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Eylea and what is it used for
2. What you need to know before you are given Eylea
3. How Eylea will be given to you
4. Possible side effects
5. Storage of Eylea
6. Contents of the pack and other information

1. What is Eylea and what is it used for

Eylea is a solution that is injected into the eye to treat certain eye diseases in adult patients, called:

• neovascular (exudative) age-related macular degeneration (AMD), commonly known as wet AMD
• vision impairment due to macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
• vision impairment due to diabetic macular edema (DME)
• vision impairment due to myopic choroidal neovascularization (mCNV)

Aflibercept, the active substance in Eylea, blocks the activity of a group of factors called vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF).

In patients with wet AMD and mCNV, when these factors are present in excess, they promote the formation of abnormal new blood vessels in the eye. These new blood vessels can cause leakage of blood components into the eye, resulting in damage to the tissues responsible for vision.

In patients with CRVO, there is a blockage of the main vein that carries blood from the retina. As a result, VEGF levels increase, causing fluid leakage in the retina and subsequent swelling of the macula (the part of the retina responsible for fine vision), known as macular edema.

When the macula fills with fluid, central vision becomes blurred.

In patients with BRVO, there is a blockage of one or more branches of the main blood vessel that carries blood from the retina. As a result, VEGF levels increase, causing fluid leakage in the retina and subsequent swelling of the macula.

Diabetic macular edema is a swelling of the retina that occurs in patients with diabetes due to fluid leakage from the blood vessels in the macula. The macula is the part of the retina responsible for fine vision. When the macula swells with fluid, central vision becomes blurred.

Eylea has been shown to stop the growth of abnormal new blood vessels in the eye that often bleed or leak fluid. Eylea may help stabilize and, in many cases, improve vision loss caused by wet AMD, CRVO, BRVO, DME, and mCNV.

2. What you need to know before you are given Eylea

You should not be given Eylea

• if you are allergic to aflibercept or any of the other ingredients of this medicine (listed in section 6)
• if you have an active infection or suspect that you may have an infection in or around the eye
• if you have severe inflammation of the eye (indicated by pain or redness)

Warnings and precautions

Tell your doctor before you are given Eylea:

• if you have glaucoma
• if you have a history of flashes of light or floaters or if you suddenly experience an increase in the size and number of floaters
• if you have had surgery or have scheduled surgery on your eye in the previous 4 weeks or in the next 4 weeks
• if you have a severe form of CRVO or BRVO (ischemic CRVO or BRVO), treatment with Eylea is not recommended

In addition, it is important that you know that:

• The safety and efficacy of Eylea when administered in both eyes at the same time have not been studied, and if used in this way, it may increase the risk of adverse reactions.
• Eylea injections may cause an increase in pressure inside the eye (intraocular pressure) in some patients within 60 minutes after injection. Your doctor will monitor you after each injection.
• If you develop an infection or inflammation inside the eye (endophthalmitis) or other complications, you may notice pain or increased discomfort in the eye, worsening of redness, blurred or decreased vision, and increased sensitivity to light. It is essential that any symptoms that appear are diagnosed and treated as soon as possible.
• Your doctor will check if you have other risk factors that may increase the likelihood of a tear or detachment of the posterior layers of the eye (retinal tear or detachment, or retinal pigment epithelial tear or detachment), in which case Eylea will be administered with caution.
• Eylea should not be used during pregnancy, unless the potential benefit outweighs the potential risk to the fetus.
• Women of childbearing age must use effective contraceptive methods during treatment and for at least 3 months after the last injection of Eylea.

The systemic use of VEGF inhibitors, substances similar to those contained in Eylea, is potentially related to the risk of blood clots that block blood vessels (arterial thromboembolic events) that can lead to a heart attack or stroke. After injection of Eylea into the eye, there is a theoretical risk that these events may occur. Data on the safety of treatment in patients with CRVO, BRVO, DME, and mCNV who have suffered a stroke, transient ischemic attack, or myocardial infarction in the last 6 months are limited. If any of these cases apply to you, Eylea will be administered with caution.

Experience is limited in the treatment of:

• Patients with DME due to type 1 diabetes.
• Diabetic patients with very high average blood sugar levels (HbA1c above 12%).
• Diabetic patients with a severe eye disease caused by diabetes, known as proliferative diabetic retinopathy.

There is no experience in the treatment of:

• Patients with acute infections.
• Patients with other eye diseases such as retinal detachment or macular hole.
• Diabetic patients with uncontrolled hypertension.
• Non-Asian patients with mCNV.
• Patients who have been previously treated for mCNV.
• Patients with damage outside the central part of the macula (extrafoveal lesions) due to mCNV.

If any of the above applies to you, your doctor will take into account this lack of information when treating you with Eylea.

Children and adolescents

The use of Eylea in children and adolescents under 18 years of age has not been studied for indications other than retinopathy of prematurity (ROP).

Other medicines and Eylea

Tell your doctor if you are using, have recently used, or might use any other medicines.

Pregnancy and breastfeeding

• Women of childbearing age must use effective contraceptive methods during treatment and for at least 3 months after the last injection of Eylea.
• There is no experience with the use of Eylea in pregnant women. Eylea should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus. If you are pregnant or plan to become pregnant, discuss this with your doctor before treatment with Eylea.
• Small amounts of Eylea may pass into breast milk. The effects on newborns/breastfed infants are unknown. Eylea is not recommended during breastfeeding. If you are breastfeeding, discuss this with your doctor before treatment with Eylea.

Driving and using machines

After injection of Eylea, you may experience some temporary visual disturbances. Do not drive or use machines while these disturbances last.

Eylea contains

• less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".
• 0.015 mg of polysorbate 20 in each 0.05 ml dose, equivalent to 0.3 mg/ml. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

3. How Eylea will be given to you

Eylea will be given to you by a doctor with experience in giving eye injections, under aseptic conditions (clean and sterile).

The recommended dose is 2 mg of aflibercept (0.05 ml).

Eylea is given as an injection into the eye (intravitreal injection).

Before the injection, your doctor will use an antiseptic eye wash to carefully clean your eye to prevent infection. Your doctor will also give you a local anesthetic to reduce or prevent any pain you may feel with the injection.

Wet AMD

Patients with wet AMD will be treated with one injection per month for the first three doses, followed by another injection after 2 months.

Your doctor will then decide if the treatment interval between injections can be maintained every 2 months or gradually extended to 2 or 4 weeks if your disease has stabilized. If your disease worsens, the interval between injections may be shortened.

You do not need to visit your doctor between injections, unless your doctor considers it necessary or you experience any problems.

Macular edema secondary to retinal vein occlusion (BRVO or CRVO)

Your doctor will determine the most suitable treatment schedule for you. Your treatment will start with a series of Eylea injections given once a month.

The interval between two injections should not be less than 1 month.

Your doctor may decide to discontinue treatment with Eylea if you do not benefit from continued treatment.

Treatment will continue with one injection per month until your disease has stabilized. You may need 3 or more monthly injections.

Your doctor will monitor your response to treatment and may continue treatment, gradually increasing the interval between injections to stabilize your disease. If your disease worsens with a longer treatment interval, your doctor will reduce the interval between injections.

Based on your response to treatment, your doctor will decide on the follow-up schedule.

Diabetic macular edema (DME)

Patients with DME will be treated with one injection per month for the first 5 consecutive doses, and then one injection every 2 months.

The interval between treatments may be maintained every 2 months or adjusted according to your disease, based on the examination by your doctor. Your doctor will decide on the follow-up schedule.

Your doctor may decide to discontinue treatment with Eylea if you do not benefit from continued treatment.

Myopic choroidal neovascularization (mCNV)

Patients with mCNV will be treated with a single injection. You will only receive further injections if your doctor's examinations show that your disease has not improved.

The interval between two injections should not be less than 1 month.

If your disease disappears and then recurs, your doctor may restart treatment.

Your doctor will decide on the follow-up schedule.

Detailed instructions for use are given at the end of this leaflet in "How to prepare and administer Eylea to adults".

If you miss a dose of Eylea

Make a new appointment to have the injection.

Stopping treatment with Eylea

Consult your doctor before stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Potentially, allergic reactions(hypersensitivity) may occur. These can be serious andrequire you to contact your doctor immediately.

With the administration of Eylea, some side effects may occur that affect the eyes and are due to the injection procedure. Some of these can be serious, including blindness, asevere infection or inflammation inside the eye(endophthalmitis), detachment, tear, or hemorrhage of the light-sensitive layer in the back of the eye(retinal detachment, retinal tear), clouding of the lens(cataract), bleeding in the eye(vitreous hemorrhage), detachment of the gel-like substance in the eye from the retina(vitreous detachment), and increased pressure inside the eye(intraocular pressure). These serious eye side effects occurred in less than 1 in 1,900 injections during clinical trials.

If you notice a sudden decrease in vision or an increase in pain and redness in the eye after the injection, contact your doctor immediately.

List of reported side effects

The following is a list of side effects that have been reported as possibly related to the injection procedure or the medicine. Do not be alarmed, you may not experience any of them. Always consult your doctor about any suspected side effect.

Very common side effects(may affect more than 1 in 10 people):

• vision decrease
• bleeding in the back of the eye (retinal hemorrhage)
• blood in the eye due to bleeding from small blood vessels in the outer layers of the eye
• eye pain

Common side effects(may affect up to 1 in 10 people):

• detachment or tear of one of the layers in the back of the eye that produce flashes of light with floating spots that may progress to vision loss (retinal pigment epithelial tear or detachment, retinal tear or detachment)
• • *Side effects known to be associated with wet AMD; observed only in patients with wet AMD.

• retinal degeneration (causing vision disturbances)
• bleeding in the eye (vitreous hemorrhage)
• certain types of clouding of the lens (cataract)
• damage to the outer layer of the eyeball (cornea)
• increased pressure inside the eye
• floaters in the vision
• detachment of the gel-like substance in the eye from the retina (vitreous detachment, resulting in flashes of light with floaters)
• feeling of having something in the eye
• increased tear production
• swelling of the eyelid
• bleeding at the injection site
• redness of the eye

Uncommon side effects(may affect up to 1 in 100 people):

• allergic reactions (hypersensitivity)**
• • **Allergic reactions were reported as rash, itching (pruritus), hives (urticaria), and some cases of severe allergic reactions (anaphylactic/anaphylactoid reactions).
• inflammation or severe infection inside the eye (endophthalmitis)
• inflammation of the iris or other parts of the eye (iritis, uveitis, iridocyclitis, cells in the anterior chamber)
• abnormal sensation in the eye
• irritation of the eyelid
• swelling of the outer layer of the eyeball (cornea)

Rare side effects(may affect up to 1 in 1,000 people)

• blindness
• clouding of the lens due to injury (traumatic cataract)

• inflammation of the gel-like substance in the eye with pus in the eye

Frequency not known(cannot be estimated from the available data):

• inflammation of the white part of the eye associated with redness and pain (scleritis)

In clinical trials, an increased incidence of bleeding from small blood vessels in the outer layers of the eye (conjunctival hemorrhage) was observed in patients with wet AMD who received treatment with anticoagulant medicines. This increased incidence was comparable in patients treated with ranibizumab and Eylea.

The systemic use of VEGF inhibitors, substances similar to those contained in Eylea, is potentially related to the risk of blood clots that block blood vessels (arterial thromboembolic events) that can lead to a heart attack or stroke. After injection of Eylea into the eye, there is a theoretical risk that these events may occur.

As with all therapeutic proteins, there is a possibility of an immune reaction (formation of antibodies) with Eylea.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eylea

• Keep this medication out of sight and reach of children.
• Do not use this medication after the expiration date shown on the carton and on the label after "EXP". The expiration date is the last day of the month indicated.
• Store in a refrigerator (between 2 °C and 8 °C). Do not freeze.
• The unopened blister pack can be stored outside the refrigerator below 25 °C for a maximum of 24 hours.
• Store in the original packaging to protect it from light.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Eylea

• The active substance is: aflibercept. A pre-filled syringe contains an extractable volume of at least 0.09 ml, equivalent to at least 3.6 mg of aflibercept. A pre-filled syringe provides a dose of 2 mg of aflibercept in 0.05 ml.
• The other ingredients are: polysorbate 20 (E 432), sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate heptahydrate (for pH adjustment), sodium chloride, sucrose, water for injections.

See "What Eylea contains" in section 2 for more information.

Appearance and pack contents of the product

Eylea is an injectable solution (injectable) in a pre-filled syringe. The solution is colorless to pale yellow.

Pack containing 1 pre-filled syringe.

Marketing authorisation holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Müllerstraße 178

13353 Berlin

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

If you want local information, scan here to access the website https://www.pi.bayer.com/eylea1.

A QR code with the link to the leaflet is included.

<------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

How to prepare and administer Eylea to adults

The pre-filled syringe must be used for the treatment of one eye only.

Do not open the blister with the sterile pre-filled syringe outside the clean room.

The pre-filled syringe contains more than the recommended dose of 2 mg of aflibercept (equivalent to 0.05 ml). The excess volume must be discarded before administration.

Before administration, the solution must be inspected visually for the presence of particles and/or a change in color or any change in physical appearance. If any of these are observed, do not use the medicine.

The unopened blister may be stored outside the refrigerator at a temperature below 25 °C for a maximum of 24 hours. After opening the blister, proceed under aseptic conditions.

For intravitreal injection, a 30 G x ½ inch (1.27 cm) injection needle should be used.

Instructions for use of the pre-filled syringe:

Leaflet: information for guardians of premature babies

Eylea 40 mg/ml solution for injection in pre-filled syringe

aflibercept

PREMATURE BABIES

Read this leaflet carefully before this medicine is administered to the baby, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask the baby's doctor.
• If you notice any symptoms of side effects, ask the baby's doctor, even if they are side effects and adverse reactions that are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Eylea and what is it used for
2. What you need to know before Eylea is administered to the baby
3. How Eylea will be administered to the baby
4. Possible side effects
5. Storage of Eylea
6. Contents of the pack and further information

1. What is Eylea and what is it used for

Eylea is a solution that is injected into the eye. Eylea belongs to a group of medicines called anti-angiogenic agents. It contains the active substance called aflibercept.

Eylea is used in premature babies to treat a condition called retinopathy of prematurity (ROP). Babies with ROP have abnormal growth of new blood vessels in the back of the eye (retina) induced by vascular endothelial growth factor (VEGF). This can cause vision problems and, in severe cases, permanent blindness.

Aflibercept, the active substance in Eylea, blocks the activity of a group of factors called vascular endothelial growth factor A (VEGF-A) and placental growth factor (PlGF).

Eylea has been shown to stop the growth of abnormal new blood vessels in the eye that often leak fluid or bleed. Eylea may help stabilize and, in many cases, improve vision loss caused by ROP.

1. What you need to know before Eylea is administered to the baby

Eylea must not be administered to the baby

• if the baby is allergicto aflibercept or any of the other ingredients of this medicine (listed in section 6)
• if the baby has an active infection or suspects that the baby may have an infection in the eye or around it (ocular or periocular infection)
• if the baby has severe inflammation of the eye (indicated by pain or redness).

Warnings and precautions

Consult the baby's doctor before Eylea is administered

• If the baby has had surgery or is scheduled for surgery on the eye in the 4 weeks prior to or following treatment.

It is also important to know that

• Eylea injections may cause an increase in pressure inside the eye (intraocular pressure) in some patients within 60 minutes after injection. The baby's doctor will monitor the baby after each injection.
• If the baby develops an infection or inflammation inside the eye (endophthalmitis) or other complications, the baby may experience redness/irritation of the eye, ocular discharge, swelling of the eyelid, and increased sensitivity to light. It is essential that any symptoms that appear are diagnosed and treated as soon as possible.

Inform the baby's doctor immediately if the baby experiences the signs or symptoms described.

• The baby's doctor will check if the baby has other risk factors that may increase the likelihood of a tear or detachment of one of the layers in the back of the eye (retinal tear or detachment) and will administer Eylea with caution.

The systemic use of VEGF inhibitors, substances similar to those contained in Eylea, is potentially associated with the risk of blockage of blood vessels by blood clots (arterial thromboembolic events) that can lead to a heart attack or stroke. After injection of Eylea into the eye, there is a theoretical risk that these events may occur.

There is no experience in the treatment of:

• Patient with acute infections.
• Patient with other eye diseases such as retinal detachment or macular hole.

If any of the above occurs to the baby, the baby's doctor will take into account this lack of information when treating the baby with Eylea.

Other medicines and Eylea

Inform the baby's doctor if the baby is taking, has recently taken, or may take any other medicine.

Eylea contains

• less than 1 mmol of sodium (23 mg) per dose; this is, essentially "sodium-free".
• 0.003 mg of polysorbate 20 in each 0.01 ml dose equivalent to 0.3 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergy.

1. How Eylea will be administered to the baby

Eylea will be administered to the baby in the eyes by a doctor with experience in administering eye injections, under aseptic conditions (clean and sterile).

The recommended dose is 0.4 mg of aflibercept (0.01 ml).

Eylea is administered as an injection into the baby's eye (intravitreal injection).

Before injection, the baby's doctor will use an antiseptic eye wash to carefully clean the baby's eye to prevent infection. The baby's doctor will also administer a local anesthetic to reduce or prevent any pain the baby may feel with the injection.

Treatment is initiated with a single injection per eye and may be administered in the second eye on the same day. The baby's doctor will monitor the baby's eye(s). Depending on how the baby responds to treatment, the baby's doctor will decide if additional treatment is required and when it should be administered. The treatment interval between two doses injected into the same eye must be at least 4 weeks.

Detailed instructions for use are presented at the end of this leaflet in "How to prepare and administer Eylea to premature babies".

Discontinuation of treatment with Eylea

If you are considering discontinuing treatment with Eylea, discuss this with the baby's doctor at your next appointment. The baby's doctor will advise and decide how long the baby should be treated with Eylea.

If you have any other questions about the use of this medicine, ask the baby's doctor.

1. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects reported in more than one premature baby were

• detachment of the layer at the back of the eye(retinal detachment)
• bleeding in the back of the eye(retinal hemorrhage)
• eye injection due to bleeding from small blood vessels in the outer layers of the eye(conjunctival hemorrhage)
• bleeding at the injection site(injection site hemorrhage)
• increased eye pressure
• swelling of the eyelid(eyelid edema)

The following are other side effectsthat have been observed with Eylea in adults. These side effects may also occur in premature babies:

• allergic reactions(hypersensitivity).

These can be serious and require immediate contact with the baby's doctor.

Side effects affecting the eyes due to the injection procedure can be serious, including

• blindness
• infectionor severe inflammationinside the eye (endophthalmitis)
• detachment, tear, or hemorrhageof the light-sensitive layer at the back of the eye (retinal detachment or tear)
• clouding of the lens(cataract)
• bleeding in the eye(vitreous hemorrhage)
• detachmentof the gel-like substance inside the eye in contact with the retina (vitreous detachment)
• increased pressureinside the eye (increased intraocular pressure), see section 2.

These serious side effects affecting the eyes occurred in less than 1 in 1,900 injections during clinical trials in adults.

It is essential to identify and treat serious side effects as soon as possible, such as an infection inside the eye or a retinal detachment.

Inform the baby's doctor immediately if you notice symptoms in the baby's eye after injection, such as

• redness/irritation
• ocular discharge
• swelling of the eyelid
• increased sensitivity to light

The following are other side effects observed in adults.

List of reported side effects

The following is a list of side effects reported as possibly related to the injection procedure or the medicine. Do not be alarmed, as the baby may not experience any of them. Always consult the baby's doctor about any suspected side effect.

Very common side effects(may affect more than 1 in 10 people):

• vision loss
• bleeding in the back of the eye (retinal hemorrhage)
• blood in the eye due to bleeding from small blood vessels in the outer layers of the eye
• eye pain

Common side effects(may affect up to 1 in 10 people):

• detachment or tear of one of the layers at the back of the eye that produce flashes of light with

• Floaters that may progress to vision loss (retinal pigment epithelial tear/detachment, retinal tear/detachment)

• *Adverse effects known to be associated with exudative DMAE; observed only in patients with exudative DMAE.

• Retinal degeneration causing vision changes
• Bleeding in the eye (vitreous hemorrhage)
• Certain types of cataract (lens clouding)
• Damage to the outer layer of the eyeball (cornea)
• Increased pressure inside the eye

• Spots in vision (floaters)
• Detachment of the gel-like substance inside the eye from the retina (vitreous detachment, resulting in flashes of light with floaters)
• Sensation of having something in the eye
• Increased tear production
• Swelling of the eyelid
• Bleeding at the injection site
• Redness of the eye

Uncommon adverse effects(may affect up to 1 in 100 people):

• Allergic reactions (hypersensitivity)**

• **Allergic reactions such as rash, itching (pruritus), hives (urticaria), and some cases of severe allergic reactions (anaphylactic/anaphylactoid) have been reported.

• Severe inflammation or infection inside the eye (endophthalmitis)
• Inflammation of the iris or other parts of the eye (iritis, uveitis, iridocyclitis, cells in the anterior chamber)
• Abnormal sensation in the eye
• Irritation of the eyelid
• Swelling of the outer layer of the eyeball (cornea)

Rare adverse effects(may affect up to 1 in 1,000 people):

• Blindness
• Clouding of the lens due to injury (traumatic cataract)
• Inflammation of the gel-like substance inside the eye
• Pus in the eye

Frequency not known(cannot be estimated from the available data):

• Inflammation of the white part of the eye associated with redness and pain (scleritis)

The use of VEGF inhibitors by systemic route, substances similar to those contained in Eylea, is potentially related to the risk of blood clots that block blood vessels (arterial thromboembolic events) that can cause a heart attack or embolism. There is a theoretical risk that this type of event may occur after injection of Eylea into the eye.

As with all therapeutic proteins, there is a possibility of an immune reaction (antibody formation) with Eylea.

If you have any doubts about any adverse effect, ask the baby's doctor.

Reporting of adverse effects

If you observe any type of adverse effect in the baby, consult the baby's doctor, even if it is a possible adverse effect that is not listed in this prospectus. You can also report it directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

1. Storage of Eylea

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date that appears on the box and on the label after "EXP". The expiration date is the last day of the month indicated.
• Store in a refrigerator (between 2°C and 8°C). Do not freeze.
• The unopened blister pack can be stored outside the refrigerator at a temperature below 25°C for a maximum of 24 hours.
• Keep in the original packaging to protect it from light.
• Medicines should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

1. Package contents and additional information

Composition of Eylea

• The active ingredient is: aflibercept. A pre-filled syringe contains an extractable volume of at least 0.09 ml, equivalent to at least 3.6 mg of aflibercept. A pre-filled syringe provides a single dose of 0.4 mg of aflibercept in 0.01 ml.

• The other ingredients are: polysorbate 20 (E 432), sodium dihydrogen phosphate monohydrate (for pH adjustment), disodium hydrogen phosphate heptahydrate (for pH adjustment), sodium chloride, sucrose, water for injectable preparations.

See "Eylea contains" in section 2 for more information.

Appearance of the product and package contents

Eylea is an injectable solution (injectable) in a pre-filled syringe. The solution is colorless to pale yellow.

Package with 1 pre-filled syringe.

Marketing authorization holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Müllerstraße 178

13353 Berlin

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of last revision of thisleaflet:

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

If you want local information, scan here to access the website https://www.pi.bayer.com/eylea1.

A QR code with the link to the leaflet is included.

<------------------------------------------------------------------------------------------------------------------

Thisinformation is intended only for healthcare professionals:

How to prepare and administer Eylea to preterm infants

The pre-filled syringe should be used for the treatment of a single eye. The extraction of multiple doses from a pre-filled syringe may increase the risk of contamination and subsequent infection.

Do not open the sterile pre-filled blister pack outside the clean room. The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

The pre-filled syringe contains more than the recommended dose of 0.4 mg of aflibercept (equivalent to 0.01 ml). For the treatment of preterm infants, the pediatric dosing device PICLEO should be used in combination with the pre-filled syringe to administer a single dose of 0.4 mg of aflibercept (equivalent to 0.01 ml). See the following section "Instructions for use of the pre-filled syringe".

Before administration, the solution should be visually inspected for the presence of particles and/or a change in color or any change in physical appearance. If you observe any of these, do not use the medicine.

The unopened blister pack can be stored outside the refrigerator at a temperature below 25°C for a maximum of 24 hours. After opening the blister pack, proceed under aseptic conditions.

For intravitreal injection, a 30 G x ½ inch (1.27 cm) injection needle should be used.

Instructions for use of the pre-filled syringe:

To prepare the pre-filled syringe for administration to preterm infants, follow steps 1 and 2 described below and then follow the instructions for use included in the packaging of the pediatric dosing device PICLEO.

1. When you are ready to administer Eylea, open the box and remove the sterilized blister pack. Carefully peel off the blister pack's laminate, ensuring the sterility of its contents. Keep the syringe in the sterile tray until you are ready for assembly.
2. Using an aseptic technique, remove the syringe from the sterilized blister pack.